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Test protocols, standard by standard

11 guides on how these tests are actually run: which standard applies to the article in front of you, what the method fixes and what it leaves to you, and where the fluid decides the result. Each one names the products it applies to.

REACH Guide #1

Nickel Release Testing Protocol (EN 1811, EN 16128 & EN 12472)

REACH Annex XVII compliance for jewellery, watches and eyewear: sample area-to-volume ratio (1 cm²/mL), one week at 30 °C, ICP-MS quantitation, and the EN 12472 wear pre-treatment for coated parts.

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MDR Guide #2

Kokubo SBF In-Vitro Bioactivity Protocol (ISO 23317)

Which edition to cite now that 2014 is withdrawn, what a positive result does and does not license you to claim, and why the fluid is only ever metastable.

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Hygiene Guide #4

Reading a Rothwell Absorption Figure (ISO 11948)

Why practical absorption is about a third of the Rothwell value, why a 13 % inter-laboratory offset makes cross-lab comparisons meaningless, and why the fluid is deliberately plain.

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Dental Guide #5

Dental Alloy Corrosion: Three Tests, Two Fluids (ISO 10271)

Static immersion runs at pH 2.3 and not in saliva, the electrochemical and tarnish tests do use saliva, and the sulphide oxidises in the direction that flatters the alloy.

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Ophthalmic Guide #6

Contact Lenses: Which Part of ISO 18369 Applies (ISO 18369)

Part 3 is the equilibrating saline and Part 4 the extractables, neither specifies a protein-bearing tear fluid, and lysozyme concentration is not lysozyme activity.

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Selection Guide #14

Eccrine Sweat & ISO 3160-2: Two Fluids, & Why EN 1811 Will Not Do

The nickel-release fluid is deliberately simple because the measurement is a trace metal figure. A corrosion study needs the opposite: the 16 amino acids that keep metal ions in solution. Why the ISO 3160-2 solution is a different chemistry entirely, and why DIN 53160 belongs with neither.

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Selection Guide #13

How Long Does a Simulated Test Fluid Last? The Four Clocks

Enzyme activity, an oxidising sulphide, a supersaturation, or nothing but the container: each fluid is ended by a different mechanism. What shortens it in your own laboratory, and what to ask a supplier who quotes one figure for everything.

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Selection Guide #12

Catheter Encrustation: What Causes It & What a Bladder Model Can Show

A urease-producing organism raises the pH until the urine can no longer hold its calcium, magnesium and phosphate. Why the pH trajectory is the driver, what prevention strategies get tested against, and why an absorbency fluid never encrusts.

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Selection Guide #11

Colour Fastness to Perspiration: ISO 105-E04, AATCC 15 & Which Edition

Colour fastness, or color fastness, is graded on the grey scale rather than measured as a concentration. Why sweat needs an acid and an alkaline bath, why AATCC 15 is a different test and not half the ISO kit, and how to check the edition you cite.

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Selection Guide #7

EN 1811, EN 16128, EN 12472 & ISO 12870: Which Nickel-Release Test?

Four standard numbers circulate for one REACH limit. Which applies to jewellery, to a piercing post and to eyewear, why EN 1811 excludes spectacle frames, and when the EN 12472 wear pre-treatment has to come first.

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Selection Guide #8

Rothwell, AUM & Catheter Encrustation Fluid: Artificial Urine Terminology

Three chemically different fluids share the name artificial urine: the ISO 11948-1 Rothwell absorbency fluid, the Griffith/Stickler AUM used for catheter encrustation, and the drug-screen product that is not a test fluid at all.

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Not sure which standard applies?

The selector takes the article you are testing and returns the standard, the fluid and the volume a campaign consumes.

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Specimen Certificate of Analysis (CoA)

SYNELYS BIOTECH
Quality Control Laboratory, Toulouse, France

CERTIFICATE OF ANALYSIS

Specimen · issued with every batch
Product: —
Test Standard: —
Batch Number: SYB-2026-0724-A
Manufacturing Date: 2026-07-24
Expiry Date: 2027-01-24
Analyzed ParameterSpecificationMethodResultStatus
…

The results relate only to the batch identified above. Measurements were made with instruments calibrated against certified reference solutions (pH buffers, KCl conductivity standard, class E2 masses) and are recorded in the batch record, which states raw-material lots and the production and control history. Synelys Biotech is not an ISO/IEC 17025 accredited laboratory and makes no claim of metrological traceability to a national standard. This is a specimen: figures are representative of a released batch and are not those of any particular lot.

Quality Visa & Batch Release:Quality manager
Released by, quality control · 2026-07-24
CoA template v2 · 2026-09-04—Page 1 of 1

Request a Free Sample (30 mL)

Test our standard-grade fluids directly on your test bench. Shipped free of charge by tracked post with specimen CoA.

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Safety Data Sheet (SDS)

Synelys Biotech SAS Quality Control Laboratory · Toulouse, France Regulation (EC) No 1907/2006 (REACH), Annex II, as amended by Regulation (EU) 2020/878

SAFETY DATA SHEET

Product range

Revision 3.0 · 2026-09-06
GHS / CLP CLASSIFICATION: MIXTURE NOT CLASSIFIED AS HAZARDOUS
Not subject to ADR Azide-free (no NaN₃) HS code 3822.90.00
SECTION 1
Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name: Simulated body fluids and normative test solutions. Product number: specific to the reference, see the product page. Mixture; no REACH registration number, the mixture is not a registrable substance.
1.2 Relevant identified uses and uses advised against
Identified use: laboratory test reagent, for conformity and development testing to the published method cited on the product page. Professional use in a laboratory only.
Uses advised against: any use in or on humans or animals; any clinical, diagnostic or therapeutic use; use as a cosmetic, a medical device, a food or a feed; supply to the general public.
1.3 Details of the supplier of the safety data sheet
Synelys Biotech SAS
Toulouse, France
hello@synelysbiotech.com
1.4 Emergency telephone number
Company: hello@synelysbiotech.com (office hours).
France, 24/7: ORFILA +33 (0)1 45 42 59 59, index of the national poison centres.
Germany, 24/7: Giftinformationszentrum, regional numbers at bvl.bund.de.
Within the EU: 112.
SECTION 2
Hazards identification
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 (CLP): the mixture is not classified. No physical, health or environmental hazard class is met.
2.2 Label elements
No hazard pictogram, no signal word and no hazard statement are required. Precautionary statements: none required. The label carries the product name, the reference standard, the batch number, the volume, the filling date, the best-before date and the statement that the product is for laboratory testing use only.
2.3 Other hazards
The mixture does not meet the PBT or vPvB criteria of Annex XIII and contains no constituent identified as having endocrine disrupting properties under Regulation (EU) 2018/1881. Spillage makes a floor slippery. A container held below its recommended temperature may freeze and split.
SECTION 3
Composition / information on ingredients
3.2 Mixtures
Aqueous mixture. Chemical characterisation: inorganic salts and organic metabolites in purified water. Composition as formulated, per litre of ready-to-use solution:
specific to the reference, see the product page
No constituent is present at or above its generic concentration limit, so the mixture stays unclassified. Water is stated for completeness. No component is an SVHC of the candidate list at or above 0.1 % w/w.
SECTION 4
First aid measures
4.1 Description of first aid measures
General: remove soiled clothing. Show this safety data sheet to the doctor.
After inhalation: not an anticipated route of exposure, the product is a non-volatile aqueous solution. Move to fresh air if an aerosol has been generated.
After skin contact: wash with water and soap. If irritation persists, seek medical advice.
After eye contact: rinse with running water for at least 15 minutes, holding the eyelids apart. Remove contact lenses if present and easy to do. If irritation persists, seek medical advice.
After swallowing: rinse the mouth and drink water. Do not induce vomiting. Seek medical advice if symptoms occur.
4.2 Most important symptoms and effects, both acute and delayed
None expected under the conditions of use. A prolonged skin contact with an acidic formulation may cause transient reddening. No delayed effect is known.
4.3 Indication of any immediate medical attention and special treatment needed
Symptomatic treatment. No specific antidote is known or required.
SECTION 5
Firefighting measures
5.1 Extinguishing media
Suitable: water spray, carbon dioxide, dry powder, alcohol resistant foam. The product itself is not combustible and does not sustain a fire.
Unsuitable: none. Choose the media appropriate to the surrounding fire.
5.2 Special hazards arising from the substance or mixture
None specific. In a fire, evaporation of the water fraction may concentrate the dissolved salts and organic constituents in the residue. Thermal decomposition of the organic fraction can release carbon oxides and, where nitrogen bearing constituents are present, nitrogen oxides and ammonia.
5.3 Advice for firefighters
As in any fire, wear self-contained breathing apparatus and full protective clothing. Do not allow firefighting water to enter drains or watercourses.
SECTION 6
Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Wear the protective equipment of section 8. Beware of a slippery floor. No evacuation or special respiratory protection is required for a laboratory scale spill.
6.2 Environmental precautions
Do not discharge a bulk quantity to a drain, to surface water or to the ground. A laboratory quantity may be flushed with plenty of water where local regulations allow it.
6.3 Methods and material for containment and cleaning up
Contain with an inert absorbent (paper, sand, diatomite, universal binder). Collect into a labelled container and dispose of according to section 13. Rinse the area with water and dry it.
6.4 Reference to other sections
Safe handling: section 7. Personal protective equipment: section 8. Disposal: section 13.
SECTION 7
Handling and storage
7.1 Precautions for safe handling
Normal laboratory practice. Avoid contact with the eyes. Do not eat, drink or smoke where the product is handled. Wash the hands after handling. Close the container after use: an opened container is exposed to microbial contamination, and this product carries no preservative.
7.2 Conditions for safe storage, including any incompatibilities
Storage: specific to the reference, see the product page
Shelf life: specific to the reference, see the product page
Container: specific to the reference, see the product page
Keep away from direct sunlight and from freezing. Do not store with strong oxidisers or strong acids. Do not return an unused portion to the original container.
7.3 Specific end use(s)
Laboratory test reagent. See section 1.2. No exposure scenario is attached: a chemical safety assessment is not required for this mixture.
SECTION 8
Exposure controls / personal protection
8.1 Control parameters
No constituent is present in a quantity that requires an occupational exposure limit to be monitored at the workplace. No DNEL or PNEC is available for the mixture; none is required, no chemical safety assessment being called for.
8.2 Exposure controls
Engineering controls: general laboratory ventilation. A fume hood is not required. An eye wash station must be accessible.
Eye and face protection: safety glasses to EN 166.
Skin protection: nitrile gloves to EN ISO 374-1, minimum thickness 0.11 mm. Breakthrough time is not determined for this mixture and must be confirmed by the glove manufacturer. Laboratory coat.
Respiratory protection: not required.
Environmental exposure controls: see sections 6.2 and 13.
SECTION 9
Physical and chemical properties
9.1 Information on basic physical and chemical properties
Physical state: Liquid, except the kits and the powder formats.
Colour: specific to the reference, see the product page
Odour: Odourless
Melting point / freezing point: Approximately 0 °C, the mixture being predominantly water. Not determined experimentally.
Boiling point or initial boiling point and boiling range: Approximately 100 °C at 1013 hPa. Not determined experimentally.
Flammability: Non-flammable. Aqueous solution with no flammable constituent.
Lower and upper explosion limit: Not applicable.
Flash point: Not applicable.
Auto-ignition temperature: Not applicable.
Decomposition temperature: Not determined.
pH: specific to the reference, see the product page
Kinematic viscosity: Not determined. Comparable to water.
Solubility: Fully miscible with water. Not determined in organic solvents.
Partition coefficient n-octanol/water (log value): Not determined. Not meaningful for a mixture of inorganic salts in water.
Vapour pressure: Approximately 23 hPa at 20 °C, that of water. Not determined experimentally.
Density and/or relative density: Approximately 1.00 to 1.02 g/cm³ at 20 °C. Not determined experimentally.
Relative vapour density: Not determined.
Particle characteristics: Not applicable.
9.2 Other information
No physical hazard class is met: the mixture is neither an oxidiser, nor a self-reactive, pyrophoric, self-heating or water-reactive mixture, nor corrosive to metals. No further safety characteristic is relevant.
SECTION 10
Stability and reactivity
10.1 Reactivity
No reactivity hazard under the recommended conditions of use and storage.
10.2 Chemical stability
Stable within the storage conditions of section 7.2 and up to the stated best-before date. Beyond it the fluid may drift outside the specification without any hazard arising.
10.3 Possibility of hazardous reactions
None known.
10.4 Conditions to avoid
Freezing, prolonged heating, direct sunlight, and an open container.
10.5 Incompatible materials
Strong oxidisers. Strong acids and bases. A chloride bearing fluid attacks unprotected carbon steel and some stainless grades: use inert labware.
10.6 Hazardous decomposition products
None under normal conditions. On thermal decomposition, see section 5.2.
SECTION 11
Toxicological information
11.1 Information on hazard classes as defined in Regulation (EC) No 1272/2008
No toxicological study has been performed on the mixture. The assessment below is derived from the constituents by the calculation method of Regulation (EC) No 1272/2008. It is not a statement that the mixture has been tested.
Acute toxicity: Not classified.
Skin corrosion/irritation: Not classified.
Serious eye damage/eye irritation: Not classified.
Respiratory or skin sensitisation: Not classified.
Germ cell mutagenicity: Not classified.
Carcinogenicity: Not classified.
Reproductive toxicity: Not classified.
STOT-single exposure: Not classified.
STOT-repeated exposure: Not classified.
Aspiration hazard: Not classified.
11.2 Information on other hazards
Endocrine disrupting properties: no constituent is identified as an endocrine disruptor under Regulation (EU) 2018/1881.
Other information: the product is not intended for human or animal use. An acidic formulation may transiently redden the skin on prolonged contact.
SECTION 12
Ecological information
12.1 Toxicity
No data available on the mixture. No constituent is classified as hazardous to the aquatic environment.
12.2 Persistence and degradability
The organic fraction (urea, lactic acid, amino acids, glucose) is readily biodegradable. The inorganic salts are not degradable and dissociate in water. No test has been run on the mixture.
12.3 Bioaccumulative potential
Not expected. The constituents are water soluble and of low molecular mass.
12.4 Mobility in soil
High. A water soluble mixture spreads with soil water.
12.5 Results of PBT and vPvB assessment
The mixture does not meet the criteria of Annex XIII. PBT: no. vPvB: no.
12.6 Endocrine disrupting properties
No constituent is identified as an endocrine disruptor.
12.7 Other adverse effects
A large discharge raises the salinity and the nutrient load of a receiving water. Do not discharge in bulk.
SECTION 13
Disposal considerations
13.1 Waste treatment methods
Product: the waste is not classified as hazardous. A laboratory quantity may go to the drain with plenty of water where local rules allow it. A bulk quantity goes to a licensed waste contractor. A batch that has been in contact with a test specimen may carry released metals and is then handled as the specimen requires, not as this sheet describes.
Waste code: assigned by the waste holder according to the origin of the waste, under Commission Decision 2000/532/EC. We do not assign it, not being the holder.
Packaging: rinse the HDPE or PP container with water; it is then recyclable with the plastics stream.
SECTION 14
Transport information
14.1 UN number or ID number
Not applicable.
14.2 UN proper shipping name
Not applicable.
14.3 Transport hazard class(es)
Not applicable.
14.4 Packing group
Not applicable.
14.5 Environmental hazards
No. Not a marine pollutant.
14.6 Special precautions for user
None. Carry upright and secured. Protect from frost in winter transport.
14.7 Maritime transport in bulk according to IMO instruments
Not applicable.
Not classified as dangerous goods under ADR, RID, ADN, IMDG or IATA. No dangerous goods declaration, no limited quantity marking and no dangerous-goods surcharge apply.
SECTION 15
Regulatory information
15.1 Safety, health and environmental regulations specific for the substance or mixture
Regulation (EC) No 1907/2006 (REACH): no constituent is on the Annex XIV authorisation list, and none is restricted under Annex XVII for this use. No constituent appears on the candidate list of substances of very high concern at or above 0.1 % w/w.
Regulation (EC) No 1272/2008 (CLP): mixture not classified.
Directive 2012/18/EU (Seveso III): not covered.
Regulation (EU) 2019/1148 (explosives precursors): no listed substance.
Regulation (EC) No 273/2004 (drug precursors): no listed substance.
National provisions: none specific. The product is not a cosmetic, a medical device, a biocide, a detergent, a food or a feed, and none of those regimes applies to it.
15.2 Chemical safety assessment
No chemical safety assessment has been carried out for this mixture. None is required: the supplier of a mixture is not obliged to carry one out under Title II of Regulation (EC) No 1907/2006.
SECTION 16
Other information
Abbreviations
ADR/RID/ADN/IMDG/IATA: transport of dangerous goods by road, rail, inland waterway, sea and air. CLP: Regulation (EC) No 1272/2008. DNEL: derived no-effect level. PNEC: predicted no-effect concentration. PBT: persistent, bioaccumulative and toxic. vPvB: very persistent and very bioaccumulative. STOT: specific target organ toxicity. SVHC: substance of very high concern. CAS: Chemical Abstracts Service.
Full text of the hazard statements used
None. No hazard statement applies to this mixture.
Revision
Revision 3.0 of 2026-09-06. This revision rewrites the sheet per product: sections 1, 2, 3, 7, 9, 11 and 16 now carry values specific to this reference rather than to the range. Section 9 is completed to the list of Annex II as amended by Regulation (EU) 2020/878, and section 11 states derived classification rather than an untested conclusion. Supersedes all earlier editions.
Notice
The information above rests on the state of our knowledge on the date of issue. It describes the product with regard to safety requirements and is not a warranty of any property. The user remains responsible for observing the law applicable to their own use, and for the risk assessment of the workplace where the product is handled. This product is for laboratory testing use only, not for use in or on humans or animals.
Download this sheet (PDF)

Batch Certificate & SDS Search

Enter the batch number printed on your bottle label (e.g. LOT-2026-0724) to access certified Quality Control records.

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